(58 days)
The Baver ADVIA IMS Albumin assay is an in vitro diagnostic device intended to measure Albumin in human serum or plasma. Measurements of albumin are used in the diagnosis, monitoring and treatment of a variety of diseases involving the liver and kidney.
The Bayer ADVIA IMS Total Bilirubin assay is an in vitro diagnostic device intended to measure bilirubin in human serum or plasma. Measurements of direct or total bilirubin, organic compounds formed during the normal and abnormal destruction of red blood cells, are used in the diagnosis, monitoring and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder disorders.
The Bayer ADVIA IMS Carbon Dioxide (CO2) assay is an in vitro diagnostic method intended to measure CO2 in human serum. Measurements of CO2 are used as an aid in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
The Bayer ADVIA IMS Digoxin assay is an in vitro diagnostic device intended to measure Digoxin, a cardioactive drug, in human serum. Measurements of Digoxin are used as an aid in the diagnosis of Digoxin overdose and in the monitoring therapeutic levels of Digoxin to ensure appropriate therapy.
The Baver ADVIA IMS HDL Cholesterol assay is an in vitro diagnostic device intended to measure HDL Cholesterol (a lipoprotein) in human serum and plasma. Such measurements are used as an aid in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.
The Bayer ADVIA IMS Inorganic Phosphorus assay is an in vitro diagnostic device intended to measure phosphorus in human serum, plasma or urine. Measurements of inorganic phosphorus are used in the diagnosis, monitoring and treatment of a variety of diseases involving the parathyroid gland and kidney, and vitamin D imbalance.
The Bayer ADVIA IMS Ion Selective Electrode assays for Sodium,Potassium,and Chloride are in vitro diagnostic devices intended to measure these analytes in human serum or plasma. Measurements of sodium are used as an aid in the diagnosis and treatment of aldosteronism, diabetes insipidus, adrenal hypertension. Addison's disease, dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium are used as an aid in the diagnosis and treatment of renal tubular disease, hyperaldosteronism, metabolic alkolosis, adrenocortical disease and diabetic ketoacidosis. Measurements of chloride are used as an aid in the diagnosis and treatment of acid-base and water imbalance. It is especially important to measure chloride during the correction of hypokalemic alkalosis and also during severe, prolonged vomiting which lowers serum chloride levels.
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This response describes the acceptance criteria and study details for several in vitro diagnostic methods on the Bayer ADVIA IMS system, based on the provided text. Since the original text combines multiple device summaries, I've organized the information by individual assay.
1. Albumin method for ADVIA® IMS
1. Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implied by Predicate Performance / Clinical Relevance) | Reported Device Performance (ADVIA IMS) |
|---|---|---|
| Imprecision | Similar to or better than predicate (Technicon CHEM 1 Albumin) | |
| Level 2.1 g/dL | (No explicit predicate data provided for this level) | Total CV(%): 1.9 |
| Level 3.4 g/dL | (No explicit predicate data provided for this level) | Total CV(%): 1.6 |
| Level 4.9 g/dL | (No explicit predicate data provided for this level) | Total CV(%): 1.5 |
| Correlation | High correlation (r ≥ 0.975 typically) and low Syx compared to predicate. | |
| Serum | - | N=53, Y=1.01X+0.55, Syx=0.13 g/dL, r=0.990 |
| Plasma(y), Serum(x) | - | N=59, Y=0.96X+0.12, Syx=0.06 g/dL, r=0.978 |
| Analytical Range | Comparable to predicate and clinically relevant | Serum/Plasma: 1 to 6 g/dL |
| Interference | Minimal effect from common interfering substances | U. Bilirubin (25mg/dL): -4.8% @ 4.2 g/dL |
| Hemoglobin (1000mg/dL): +5.7% @ 3.5 g/dL | ||
| Lipids (1000mg/dL): -2.9% @ 3.5 g/dL |
2. Sample size and data provenance (test set):
- Serum Correlation: N=53. Data provenance is not specified (retrospective or prospective, country of origin).
- Plasma/Serum Correlation: N=59. Data provenance is not specified.
- Imprecision: Not explicitly stated how many samples per level, but standard practice involves running multiple replicates over several days. Data provenance not specified.
- Interfering Substances: For each substance, 1 sample was tested at a specific albumin concentration. Data provenance not specified.
3. Number of experts and qualifications (ground truth for test set):
Not applicable. This is an in-vitro diagnostic device for measuring a chemical analyte. The ground truth would be established by the reference method (predicate device or other accepted laboratory method).
4. Adjudication method (test set):
Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study:
Not applicable. This is an in-vitro diagnostic device without human-in-the-loop performance.
6. Standalone performance (algorithm only without human-in-the-loop):
Yes, the provided data represents the standalone performance of the ADVIA IMS Albumin method directly compared to the predicate device (Technicon CHEM 1 Albumin) and its own performance characteristics.
7. Type of ground truth used:
For correlation, the predicate device (Technicon CHEM 1 Albumin) served as the comparison system, implying its measurements were considered the "ground truth" or reference. For imprecision, the measured values are compared against themselves over multiple runs.
8. Sample size for training set:
Not applicable. For this type of in-vitro diagnostic device, there isn't a "training set" in the machine learning sense. Performance is validated through analytical studies (imprecision, correlation, interference).
9. How ground truth for training set was established:
Not applicable.
2. T.Bilirubin method for ADVIA® IMS
1. Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implied by Predicate Performance / Clinical Relevance) | Reported Device Performance (ADVIA IMS) |
|---|---|---|
| Imprecision | Similar to or better than predicate (Technicon CHEM 1 T.Bilirubin) | |
| Level 1.1 mg/dL | Predicate: 9.1% Total CV | Total CV(%): 7.0 |
| Level 4.5/5.0 mg/dL | Predicate: 4.8% Total CV | Total CV(%): 5.1 |
| Level 17.0/20.0 mg/dL | Predicate: 2.6% Total CV | Total CV(%): 2.4 |
| Correlation | High correlation (r ≥ 0.975 typically) and low Syx compared to predicate. | |
| Serum | - | N=58, Y=1.08X-0.11, Syx=0.26 mg/dL, r=0.998 |
| Plasma(y), Serum(x) | - | N=57, Y=1.01X-0.01, Syx=0.02 mg/dL, r=0.994 |
| Analytical Range | Comparable to predicate and clinically relevant | Serum/Plasma: 0 to 45 mg/dL |
| Interference | Minimal effect from common interfering substances | Hemoglobin (500mg/dL): +1% @ 6.9 mg/dL |
| Lipids (500mg/dL): -34% @ 6.7 mg/dL |
2. Sample size and data provenance (test set):
- Serum Correlation: N=58. Data provenance is not specified (retrospective or prospective, country of origin).
- Plasma/Serum Correlation: N=57. Data provenance is not specified.
- Imprecision: Not explicitly stated how many samples per level, but standard practice involves running multiple replicates over several days. Data provenance not specified.
- Interfering Substances: For each substance, 1 sample was tested at a specific T.Bilirubin concentration. Data provenance not specified.
3. Number of experts and qualifications (ground truth for test set):
Not applicable. This is an in-vitro diagnostic device for measuring a chemical analyte. The ground truth would be established by the reference method (predicate device or other accepted laboratory method).
4. Adjudication method (test set):
Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study:
Not applicable.
6. Standalone performance (algorithm only without human-in-the-loop):
Yes, the provided data represents the standalone performance of the ADVIA IMS T.Bilirubin method directly compared to the predicate device (Technicon CHEM 1 T.Bilirubin) and its own performance characteristics.
7. Type of ground truth used:
For correlation, the predicate device (Technicon CHEM 1 T.Bilirubin) served as the comparison system, implying its measurements were considered the "ground truth" or reference. For imprecision, the measured values are compared against themselves over multiple runs.
8. Sample size for training set:
Not applicable.
9. How ground truth for training set was established:
Not applicable.
3. CO2 Method for the Bayer ADVIA Integrated Modular System (IMS)
1. Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implied by Predicate Performance / Clinical Relevance) | Reported Device Performance (ADVIA IMS) |
|---|---|---|
| Analytical Range | Comparable to predicate and clinically relevant | 10 to 40 mEq/L |
| Precision (Total) | Similar to or better than predicate (Technicon CHEM 1 CO2) | |
| @ 11.98 mEq/L | Predicate: 4.5% @ 14 mEq/L | 5.3% |
| @ 19.10 mEq/L | Predicate: 3.8% @ 22 mEq/L | 4.3% |
| @ 28.39 mEq/L | Predicate: 3.3% @ 28 mEq/L | 3.0% |
| Correlation | High correlation (r ≥ 0.975 typically) and low Syx compared to predicate. | N=106 (53 pairs), Y=0.99X+0.41 mEq/L, r=0.993, Syx=0.999 mEq/L |
| Interference | Minimal effect from common interfering substances (e.g., |
§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.